FDA seeks more evidence on cancer drugs- - The US Food and Drug Administration seeks evidence on Sunesis Pharmaceuticals Inc. before the approval for its cancer drugs.
On October, vosaroxin drug failed a late-stage trial as it did not significantly improve the overall survival of patients compared with a placebo.
According to Sunesis Pharma, the FDA wanted the additional evidence before Sunesis files its marketing application for the cancer drug.European regulators suggested it seek marketing approval for Qinprezo,or vosaroxin, in patients 60 years and older because they need a new treatment the most, and benefited the most from treatment with the cancer drug during the company’s late-stage clinical trial. If the drug were approved only for elderly patients, that would likely limit its use.
Sunesis pharma has been studying the cancer drug as a treatment for acute myeloid leukemia in patients who have suffered a relapse or whose cancer did not respond to previous treatment.
Shares of Sunesis Pharmaceuticals Inc. tumbled 78 percent on Oct. 6, the day those results were announced, and closed at $1.46. The stock has gradually recovered since then and closed at $3.47 on Thursday.
The European Medicines Agency (EMA) however, gave the company the nod to submit a marketing application for vosaroxin.
Almost 15,000 people are diagnosed with AML in the United States each year, according to the National Cancer Institute.
Aside from chemotherapy agent cytarabine, AML is currently treated with another standard chemotherapy daunorubicin, and with stem cell transplant.
RBC Capital Markets analyst Adnan Butt said. “The EMA has a history of taking in the whole picture while the FDA historically sticks to statistics, decision on the European approval to come through by 2016.
Approval in the United States, however, can be delayed by a few years as the company would need to run additional trials, he added.IMAGE/fdadrugs